Breaking News Instant updates and real-time market news.

2016-10-04 16:03:11

KIN

Kindred Biosciences

$5.12

-0.15 (-2.85%)

16:03

10/04/16

10/04

16:03

10/04/16

16:03

Kindred Biosciences receives technical section letter from FDA

Kindred Biosciences announced it has received a technical section complete letter for effectiveness from the FDA's Center for Veterinary Medicine for Zimeta approving the technical section.The basis for this complete letter was a multicenter, randomized, blinded, placebo-controlled pivotal study that enrolled 138 horses to assess the effectiveness of Zimeta. KindredBio has responded to the first round of review by the FDA for the CMC technical section. KindredBio is in the process of responding to the first round of review by the FDA on the safety technical section. KindredBio expects the approval of Zimeta in the first half of 2017 if the FDA review process is rapid.

As noted earlier, BMO Capital downgraded Kindred Biosciences to Market Perform from Outperform. After the pivotal field study of company's SentiKind, for post-operative pain in dogs, did not meet its primary endpoint, BMO Capital downgraded the stock based on concerns about the company's execution and low expectations for the rest of the company's pipeline. Target to $5 from $14.

UP AFTER EARNINGS: Cintas (CTAS), up 2.9%... Micron (MU), up 2.8%. ALSO HIGHER: Editas Medicine (EDIT), up 3.1% after it received the EMA's orphan medicinal product designation for EDIT-101... Twitter (TWTR), up 1.8% after it said it will start testing longer, 280-character tweets with a small group. DOWN AFTER EARNINGS: Nike (NKE), down 3.2%. ALSO LOWER: Kornit Digital (KRNT), down 12.2% after it cut its third quarter revenue guidance... Westlake Chemical Partners (WLKP), down 8.3% after it filed to sell 4.5M units for limited partners... Intra-Cellular (ITCI), down 7.2% after it filed to sell $150M in common stock... Ascendis Pharma (ASND), down 4.3% after it announced an offering of $125M of ADSs.